Method and apparatus for inhibiting proximal junctional failure

ABSTRACT

Methods and devices are disclosed for inhibiting proximal junctional failure in a patient having posterior spinal instrumentation. One or more tension bands can be threaded through transverse bores in a spinous process of a vertebral body of a spine, superior and adjacent an uppermost instrumented vertebral body. Tension is applied to bias the spinous processes together and also in an inferior direction. The tension band is locked with respect to the spine, to maintain tension.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND Field

The present disclosure generally relates to vertebral stabilization,and, more specifically, devices and methods to inhibit adjacent levelkyphosis and/or adjacent level failure such as proximal junctionalfailure.

Description of the Related Art

Adjacent level failure is a failure of a vertebral column that mayfollow a less serious condition of adjacent level kyphosis, which is anincreased posterior convexity of the vertebral column as viewed from theside. Adjacent level kyphosis and failure, particularly proximaljunction kyphosis (PJK) and proximal junction failure (PKF), are knowncomplications for patients who undergo spinal surgery (e.g., spinalfusion surgery). To straighten a distracted spine (e.g., scoliosis), itis known to use vertebral osteosynthesis equipment including, but notlimited to, anchoring members for anchoring to the vertebrate (e.g.,pedicle screws and/or lamina hooks), connecting rods, and connectors forconnecting the rods to the anchoring members, to form a rigid posteriorinstrumentation construct. However, a spine of the patient who underwentspinal surgery using conventional posterior instrumentation mayexperience increased loading on vertebral segments adjacent to theinstrumentation. The increased load in the adjacent segments may resultin adjacent level kyphosis and/or even failure, which may require arepeat, revisionary surgery.

The prevalence and consequences of PJK and PJF are not fully understood.However, different authors have reported the prevalence of PJK followingspinal deformity fusion surgeries as ranging from 20% to 39%. Theprevalence of PJF has been reported to range between 1.4% and 35%. Thecost of revision surgery following PJF has been estimated to be about$77,000.

SUMMARY

The systems, methods, and devices of this disclosure each have severalinnovative aspects, no single one of which is solely responsible for thedesirable attributes disclosed herein.

The present disclosure provides instruments and methods for inhibitingadjacent junctional failure such as proximal junctional failure in apatient having posterior spinal instrumentation. An embodiment of themethod can comprise the steps of creating a first transverse borethrough a spinous process of a vertebral body of a spine, superior andadjacent an uppermost instrumented vertebral body. A second transversebore is created through a spinous process of the uppermost instrumentedvertebral body. An optional third transverse bore may be created througha spinous process of a vertebral body inferior and adjacent theuppermost instrumented vertebral body;

A tensioning band is threaded through the first, second and third bores,and proximally retracted to bias the upper and lower spinous processestogether and also to bias all involved spinous processes in an inferiordirection. The tension band is locked with respect to the spine tomaintain tension.

The locking step may comprises attaching a connector to the posteriorinstrumentation and locking the tension band to the connector.Alternatively the locking step comprises attaching a connector to thespine and locking the tension band to the connector.

The tension band may have first and second ends, and both the first andsecond ends exit the first transverse bore and are locked under tensionto a connector secured with respect to the spine. The spinalinstrumentation may include a left rod and a right rod, and the tensionband is secured to the connector at a point that is medial to the leftand right rods.

The creating a first transverse bore step may comprise locating opposingjaws of a bone punch on opposing sides of the spinous process, andpunching the first transverse bore. The method may additionally comprisethe step of inserting a liner into at least the first transverse bore,prior to the threading a tension band step. The inserting a liner stepmay comprise inserting a grommet into at least the first transversebore.

The stabilization or force distribution system of the present inventionseeks to modify the forces across the UIV and UIV−1 junction, possiblysupplementing the interspinous and supraspinous ligament complexes abovethe upper instrumented level. In one implementation of the invention,the spinous process of the uppermost and the lowermost of the selectedgroup of three vertebral bodies centered on UIV will be biased towardseach other, and all three will be biased in an inferior direction andheld in place by locking such as to the posterior instrumentation.

Also disclosed herein are embodiments of a method of inhibiting proximaljunctional failure in a patient having posterior spinal instrumentation,comprising the steps of creating a first transverse bore through aspinous process of a vertebral body of a spine, superior and adjacent anuppermost instrumented vertebral body, a second transverse bore througha spinous process of the uppermost instrumented vertebral body, and athird transverse bore through a spinous process of a vertebral bodyinferior and adjacent the uppermost instrumented vertebral body,threading a tension band having a first end and a second end through thefirst, second and third bores, extending the tension band inferiorly ofthe third transverse bore, under tension, and locking the tension bandwith respect to the spine.

In some embodiments, the locking can comprise attaching a connector tothe posterior spinal instrumentation and locking the tension band to theconnector. In some embodiments, the locking can comprise attaching aconnector to the spine and locking the tension band to the connector. Insome embodiments, the tension band has first and second ends, and boththe first and second ends exit the first transverse bore and are lockedunder tension to a connector secured with respect to the spine. In someembodiments, the posterior spinal instrumentation can include a left rodand a right rod, and the tension band is secured to the connector at apoint that is medial to the left and right rods.

In some embodiments, the creating a first transverse bore step cancomprise locating opposing jaws of a bone punch on opposing sides of thespinous process, and punching the first transverse bore. In someembodiments, the method can further comprise inserting a liner into atleast the first transverse bore, prior to the threading a tension bandstep. In some embodiments, the inserting the liner can compriseinserting a grommet into at least the first transverse bore.

In some embodiments, the tension band can extend through the first borein a first direction, the second bore in a second direction generallyopposite the first direction, and the third bore in the first direction,wherein the first end of the tension band is located one a first side ofthe spinous process and where the second end of the tension band islocated on a second side of the spinous process. In some embodiments,the second end of the tension band can extend through the first bore inthe first direction. In some embodiments, the method can furthercomprise extending a second tension band having a first end and a secondend through the first bore, the second bore, and the third bore. In someembodiments, the second tension band can extend through the first borein the second direction, the second bore in the first direction, and thethird bore in the second direction, wherein the first end of the secondtension band is located on the second side of the spinous process andthe first end of the second tension band is located on the first side ofthe spinous process. In some embodiments, the second end of the secondtension bands can extend through the first bore in the second direction.

Also disclosed herein are embodiments of a system of inhibiting proximaljunctional failure in a patient having posterior spinal instrumentation,the system comprising at least one tension band having a first end and asecond end, at least one connector configured to be attached to thepatient's spine or the posterior spinal instrumentation, wherein the atleast one tension band is configured to pass through a plurality oftransverse bores in at least two vertebrae of the patient's spine,wherein the first end of the at least one tension band and the secondend of the at least one tension band are locked under tension in the atleast one connector.

In some embodiments, the system can further comprise a bone punchconfigured to create the plurality of transverse bores. In someembodiments, the system can comprise a plurality of connectors andwherein the first end of the at least one tension band is locked undertension in a first of the plurality of connectors and the second end ofthe at least one tension band is locked under tension in a second of theplurality of connectors. In some embodiments, the first of the pluralityof connectors and the second of the plurality of connectors can beconfigured to be located on opposite transverse sides of the patient'sspine. In some embodiments, the at least one tension band can comprise afirst tension band and a second tension band each having a first end anda second end, and wherein the at least one connector comprises a firstconnector and a second connector, wherein the first end and the secondend of the first tension band are locked under tension in the firstconnector, and wherein the first end and the second end of the secondtension band are locked under tension in the second connector.

In some embodiments, the first connector and the second connector can beconfigured to be located on opposite transverse sides of the patient'sspine.

Further disclosed herein are embodiments of a kit which can include thesystem/equipment discussed herein.

Any feature, structure, or step disclosed herein can be replaced with orcombined with any other feature, structure, or step disclosed herein, oromitted, depending upon the desired clinical result. For purposes ofsummarizing the disclosure, certain aspects, advantages and novelfeatures of the embodiments have been described herein. It is to beunderstood that not necessarily any or all such advantages may beachieved in accordance with any particular embodiment of the inventiondisclosed herein. Thus, the invention may be embodied or carried out ina manner that achieves or optimizes one advantage or group of advantagesas taught or suggested herein without necessarily achieving otheradvantages as may be taught or suggested herein. No individual aspectsof this disclosure are essential or indispensable.

All of these embodiments are intended to be within the scope of thepresent disclosure. Further features and advantages of the embodimentswill become apparent to those skilled in the art in view of the DetailedDescription which follows when considered together with the attacheddrawings and claims, the invention not being limited to any particularpreferred embodiment(s) disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed aspects will hereinafter be described in conjunction withthe appended drawings and appendices, provided to illustrate and not tolimit the disclosed aspects, wherein like designations denote likeelements.

FIG. 1A illustrates a posterior view of a vertebral column.

FIG. 1B illustrates a sagittal view of the vertebral column of FIG. 1A.

FIG. 2A illustrates a posterior view of a vertebral column with anembodiment of vertebral osteosynthesis equipment described herein.

FIG. 2B illustrates a sagittal view of the vertebral column of FIG. 2A.

FIG. 3A illustrates a perspective view of an embodiment of a connectordescribed herein.

FIG. 3B illustrates a cross-section view of the connector of FIG. 3A ina longitudinal direction, two tightening screws of the connector beingout of their tapped receiving bores.

FIG. 3C illustrates a cross-section view of the connector of FIG. 3A ina longitudinal direction, when the connector is engaged on a connectingrod, a ligament is engaged thereon, and the tightening screws are placedin the receiving bores.

FIG. 4A illustrates a posterior view of the vertebral columnillustrating an embodiment of a method explained herein.

FIG. 4B describes a sagittal view of the vertebral column of FIG. 4A.

FIG. 5 illustrates a posterior view of a vertebral column illustratingan embodiment of a method or system explained herein.

FIG. 6A illustrates a posterior view of a vertebral column describing anembodiment of a method or system explained herein.

FIG. 6B shows a sagittal view of the vertebral column of FIG. 6A.

FIGS. 7-8 illustrate a posterior view of a vertebral column illustratingan embodiment of a method or system explained herein.

FIGS. 9-13 illustrate example distal ends of an embodiment of a plierstype instrument as discussed herein.

FIG. 14 illustrates an embodiment of a grommet in position.

FIG. 15 is a perspective view of a modified connector.

FIG. 16 is a side elevational view of the connector of FIG. 15.

FIG. 17 is a perspective view of a further modification to theconnector.

FIG. 18 is a side elevational view of the connector FIG. 17.

FIGS. 19A-19E illustrates an embodiment of a method of installing twotension bands into a vertebral column.

FIGS. 20A-20B illustrate an embodiment of a method of installing asingle tension band into a vertebral column.

DETAILED DESCRIPTION

Disclosed herein are embodiments of systems, methods, assemblies, anddevices which can be incorporated into spinal deformity surgery.Advantageously, tension can be applied onto a patient's spine which canprevent the need for further corrective surgery (e.g., revisionsurgery). The disclosed techniques and equipment can be used withpreviously installed spinal equipment, as well as during new surgicalprocedures. Further, modifications can be made to previously installedspinal equipment in order to incorporate the below disclosed techniques.Advantageously, the disclosed systems can keep the integrity of thesupra and intra spinous ligament and focus on anchorage through thespinous process.

Spinal deformity surgery commonly involves implantation of multilevelspinal fusion instrumentation to reshape and rigidly constrain a sectionof the spine. Post-surgery, a patient may experience an increase inspinal stiffness and an increased loading within spinal segmentsadjacent to the end of the instrumentation. The increased load in theadjacent segments may result in adjacent level kyphosis or failure,which may require revision surgery. Thus, vertebral osteosynthesisequipment which is configured to distribute the increased loading withinadjacent segments to other segments would be desirable to minimize theoccurrence of or reduce the severity of adjacent level kyphosis and/orfailure.

FIGS. 1A and 1B illustrate posterior and sagittal views of a vertebralcolumn 100, respectively. The vertebral column 100 comprises a series ofvertebrae 101. Each vertebra 101 comprises a vertebral body 102, twotransverse processes 104 whose ends at least partially point to lateraldirections (e.g., left and right directions, respectively), and aspinous process 106 whose end dominantly points to the posteriordirection. Each set of adjacent vertebral bodies are separated by anintervertebral disc 108.

FIGS. 2A and 2B illustrate posterior and sagittal views of the vertebralcolumn 100 with conventional vertebral osteosynthesis equipment 130 aswell as a junction stabilization system in accordance with certainimplementations of the present disclosure. With reference to FIGS.2A-2B, the vertebral osteosynthesis equipment 130 includes one or morerods 132 and one or more screws 134 (e.g., pedicle screws and/or laminahooks) and may further include one or more transverse connecting rods asis understood in the art. The rods 132, screws 134 and connecting rodsthus rigidly hold the vertebrae 101 in place. Each of the one or moreconnecting rods 132 may be mounted on the left or right side of thevertebral column 100 along the longitudinal length of the vertebralcolumn 100. The one or more connecting rods 132 may extend along thelongitudinal lengths of two or three or more vertebrae 101. In oneexample, as shown in FIG. 2A, the vertebral osteosynthesis equipment 130may comprise two connecting rods 132, and the two connecting rods 132may be mounted one on the left and one on the right side of the spinousprocess 106 near the bases of the transverse processes 104 of thevertebrae 101. The two connecting rods may span along the longitudinallengths of three or four or more adjacent vertebrae 103. In someembodiments, the one or more connecting rods 132 may be cylindricallyshaped and may be made of metal such as stainless steel, titanium, ornitinol. In some embodiments, the equipment 130 may not need to bemodified for attachment of the disclosed systems. In alternateembodiments, modifications may be made.

With reference to FIG. 2B, the one or more screws 134 (e.g., pediclescrews and/or lamina hooks) are configured to anchor the one or moreconnecting rods 132 to or near the bases of the transverse processes 102of the vertebrae 101 (e.g., laminae). That way, the one or more screws134 are configured to hold the one or more vertebrae 101 together. Eachscrew 134 comprises a head 136 and an anchor 138 such as a threadedshaft. The head 136 includes a bore 137 through which one of the one ormore connecting rods 132 is configured to pass and a fastener 138configured to fasten the head 136 of the screw 134 to the connecting rod132. In one example, as shown in FIG. 2B, the fastener 138 may comprisea screw with threads that are configured to be placed into a transversehole whose length is perpendicular to that of the bore 137 and interlockwith threads on the inner surface of the transverse hole. The anchor 138is configured to be inserted (e.g., drilled, etc.) into the base of thetransverse process 102 of the vertebra 101 and hold the screw 134 insidethe vertebra 101. In one example, as shown in FIG. 2B, the anchor 138may comprise an elongate body with threads on its surface. When theanchor 138 is inserted by rotation into the vertebra 101, the threads ofthe anchor 138 are configured to facilitate anchoring of the screw 134to the vertebra 101. While a particular approach is disclosed withrespect to FIGS. 2A-2B, the below disclosed techniques can be utilizedwith variations of equipment and attachment techniques.

FIG. 2B identifies the uppermost instrumented vertebra (UIV) as well asthe UIV−1 and UIV+1 adjacent vertebral bodies. The stabilization orforce distribution system of the present disclosure seeks to modify theforces across the UIV and UIV−1 junction, possibly supplementing theinterspinous and supraspinous ligament complexes above the upperinstrumented level. Alternatively, the system may be used on thelowermost instrumented vertebra (LIV) or any vertebra in between. Thismay be accomplished using the tension/band/strap system described ingreater detail below, to secure the UIV−1 through UIV+1 spinousprocesses together. Alternatively, the stabilization system may be usedto secure UIV or UIV−1 to UIV+1 or UIV+2 or higher, including allintervening spinous processes, depending upon the desired clinicalresponse. The secured group of spinous processes can then be biaseddownwardly by the stabilization system (such as a band and connector asdiscussed below), which can be thereafter locked with respect to thespine. The band may be locked to a spine screw, a rod, a transverse baror directly to the spine such as by wrapping around bony structures orpassing through a bore created for that purpose, and the particularconnection is not limiting.

Thus, in accordance with one aspect of the present disclosure, aselected group of two or three or more adjacent vertebral bodies can besecured together in a manner that distributes forces experienced at thejunction between an instrumented vertebral body and an adjacentuninstrumented vertebral body. For example, if the superior mostinstrumented vertebral body UIV is T10, the three vertebral bodiesT9-T11 will preferably be stabilized as described herein. However, moreor less vertebral bodies can be stabilized as well. For example T9-T10,T10-T11, T8-T12, T8-T11, or T9-T12. In some embodiments, two, three,four, five, six, seven, eight, nine, or ten vertebral bodies can bestabilized together. In some embodiments, more than two, three, four,five, six, seven, eight, nine, or ten vertebral bodies can be stabilizedtogether. In some embodiments, less than three, four, five, six, seven,eight, nine, or ten vertebral bodies can be stabilized together. In oneimplementation, the spinous process of the uppermost and the lowermostof the selected group of three vertebral bodies centered on UIV (or LIV)will be biased towards each other, and all three will be biased in aninferior direction and held in place by locking to the posteriorinstrumentation. This may be accomplished using any of a variety ofcustomized clamps or fixtures, or, as described in greater detail below,by weaving one or two or more flexible tension bands through and oraround the spinous process of the involved vertebral bodies.

With reference to FIG. 2A, at least a first tension band 120 andpreferably also a second tension band 122 are configured to pass throughholes (e.g., punches, lumens) 111, 113 and 115 through the spinousprocess on the vertebrae 101 and bias the spinous processes together.The holes can extend through other portions of the vertebrae as well.The tension band (e.g., strap, cord, wires) may be, for example,Mersilene tape (Ethicon, Summerville, N.Y.) or other flexible implantgrade material having sufficient resistance to elongation. The tensionbands may alternatively be made of woven or multi-strand metallicmaterials such as Nitinol or stainless steel, or polymeric materialssuch as polyester, polyamide, polyethylene, polyethylene polycarbonate,poly(ethylene terephthalate) (PET), and polyetheretherketone (PEEK). Inother embodiments, the one or more tension band 120 and/or 122 may bemade of plaits of polyester fibers, with a circular or flat section. Insome embodiments, the tension band 120/122 may be the same, and inalternate embodiments they may differ in, for example, size, shape, ormaterial. The particular material/dimensions of the tension band wires120/122 are not limiting.

In one example, as shown in FIG. 2A, the tension bands 120 and 122 maybe configured to pass through holes 111, 113 and 115 on three adjacentvertebrae 105, two of which are secured by bone screws to connectingrods 132, such that the woven tension band construct spans the proximaljunction. The two ends of each of the tension bands 120 and/or 122 maybe anchored to the one or more connectors 140, or directly to existingequipment or lower vertebrae. In some embodiments, the tension band120/122 may not pass through holes, but instead may be attached directlyto the vertebrae 105, such as at a radially outermost surface. In someembodiments, the tension band 120/122 may pass through empty spaces inor between vertebrae.

With reference to FIG. 2B, the connectors 140 are configured to anchorfree ends of each of the tension bands 120 and 122, or other portions ofthe tension band 120 and 122. The connectors 140 can have a lockinginterface such as a bore (not illustrated) for receiving a connectingrod 132 or a transverse bar (not illustrated). The connector 140 asillustrated is coupled to a corresponding connecting rod 132, such aswith the connecting rod 132 clamped inside the bore of the connector140. In one example, as shown in FIG. 2B, a left and a right connector140, are each coupled to a corresponding left and right connecting rods,respectively, via the locking interfaces (not shown) of the connectors140.

In the construct illustrated in FIG. 2A, both free ends of the firstband 120 extend inferiorly on the left side of the spine, and both freeends of the band 122 extend inferiorly on the right side of the spine.Each of the first and second bands 120/122 may be provided with uniquefirst and second connectors. Alternatively, the free ends of both thefirst and second bands 120/122 may be locked to a single connector. In asingle connector embodiment, the connector is preferably located alongthe sagittal plane to provide a slightly medially directed bias on thebands, though the particular position is not limiting. The singleconnector may be carried by a transverse bar, or may include a firstlocking interface for connecting to a first rod and a second lockinginterface for connecting to a second rod. In a two connectorimplementation, the first and second connectors may be located such thatthe longitudinal axis of the segments of the bands between the aperture111 and the point of attachment to the connector extend downwardlyapproximately parallel to the sagittal plane or inclined medially in thedownward direction, though again the particular positioning is notlimiting.

FIGS. 3A-3C illustrates the detailed structure of one connector 140useful for connecting the tension band to the instrumentation. Theconnector 140 is configured to secure the one or both ends of a tensionband to the posterior instrumentation, such as to connecting rod 132.With reference to FIG. 3A, the connector 140 includes a first portion210, in which a first locking interface such as conduit 211 is formedfor engaging on the connecting rod 132, and a second portion 212 inwhich a second conduit 213, for receiving the one or more tension bands120 and/or 122, is formed side-by-side.

With reference to FIGS. 3B-3C, the first conduit 211 communicates with atapped bore 215 for receiving a screw/bolt/attachment member 216 fortightening the connecting rod 132 in said conduit 211. This conduit 211can include, on the side diametrically opposite the bore 215, a roundedlongitudinal recess 217 whereof the connection to the rest of theconduit 211 forms two longitudinal edges (shown in FIG. 3B). Thepresence of these edges is favorable to complete immobilization of theconnector 140 in rotation relative to the bar 130 when the screw 216 istightened. In alternative embodiments, the edges may not be included. Infurther alternate embodiments, more significant edges (e.g., triangular,rectangular, polygonal shaped) may be incorporated to furtherimmobilize.

The second conduit 213 is separate from the first conduit 211 and is notin communication therewith. In alternate embodiments, they may beconnected. It can be rectilinear between the opening 218 for insertiontherein of the one or two or more tension band wires 120 and/or 122 andthe opening 213 opposite that conduit 211. The latter may be formed atan angle such as about 45° relative to a length of the connector 140defined jointly by said first portion 210 and second portion 212, suchthat the opening 218 emerges on a side of the second portion 212substantially opposite the first portion 210, or remote from said firstportion 210. In some embodiments, where a single connector 140 is used,the connector 140 can contain an additional conduit so that each tensionband 120/122 is in a separate conduit. U.S. Pat. No. 9,314,275, issuedApr. 19, 2016, describes the connector in greater detail and is herebyincorporated by reference in its entirety herein.

Each of the connecting rod conduit 211 and tension band conduit 213 hasa central longitudinal axis which extends approximately in parallel withthe side walls of the respective conduit. The longitudinal axis of thesecond conduit 213 may be oriented relative to the longitudinal axis ofthe first conduit 211 such that when the connector is mounted to aposterior rod, the longitudinal axis of the second conduit 213 extendsat an angle of no more than about 25°, preferably no more than about15°, and more preferably within about 5° of the straight line betweenthe closest opening of second conduit 213 and the spinous process borefrom which the tension band exits, typically the first transverse bore.The point at which the tension band enters the connector is typically ata point that is medial to the left and right posterior fusion rods, andpreferably within about 1.0 inches or 0.75 inches or 0.5 inches of thesagittal plane of the spine.

FIGS. 4A-B illustrate procedural steps of an embodiment of a method forholding one or more vertebrae together using one or more tension bands.Some components of the vertebral osteosynthesis equipment describedabove (e.g., vertebral osteosynthesis equipment 130, one or moreconnecting rods 132, one or more screws 134, one or more connectors 140)may not be shown in FIGS. 4A-B. However, it will be appreciated that oneor more steps of the method described below may be conducted with one ormore components of the vertebral osteosynthesis equipment (e.g.,vertebral osteosynthesis equipment 130, one or more connecting rods 132,one or more screws 134, or one or more connectors 140).

Referring to FIGS. 4A-4B, transverse holes 111, 113 and 115 are made ator near the bases of the spinous processes 104 (e.g., preferably not thelaminae) of the vertebrae of a patient, though the particular locationisn't limiting. The transverse holes 111 113 and 115 are configured forreceiving the tension bands therethrough. Alternatively, agrommet/ring/liner may be secured to one or more of the spinousprocesses, for receiving the tension band therethrough. The grommet maybe provided with one or more attachment structures such as a firstflange for securing to the spinous process. In one embodiment, a secondflange is also provided, spaced apart from the first flange to receivethe spinous process there between. A locking pin such as a bone screw orother connector may be utilized to secure the opposing first and secondflanges through the spinous process and thereby secure the ring to thebone.

Although the vertebrae 170, 172, and 174 are referred to as top, middle,and bottom vertebrae, it will be appreciated that the vertebrae 172 and174 may be two vertebrae on which the connecting rods 132 are mounted,and the vertebra 170 is a UIV+1 vertebra without the connecting rods 132and most adjacent to the two vertebrae 172 and 174 on which theconnecting rods 132 are mounted.

The transverse holes through the spinous process may be formed (e.g.,drilled, punched, created) with the aid of a drill guide. The drillguide may guide the drill bit to a point which is approximately centeredon the spinous process in the inferior-superior direction. The drillguide may also guide the drill bit to a point adjacent the base of thespinous process.

The edges of the drilled bore may be sufficiently rough to inhibitfeeding the free end of the tension band there through. A drill boreliner, having a lumen defined by a tubular wall, may be placed withinthe bore to facilitate threading the end of the band therethrough. Theliner may remain in the bore after threading the band, or may beremoved. In some embodiments, the liner is biodegradable. The tubularwall may be provided with a radially outwardly extending annular flange,to seat against the side of the spinous process and retain the liner inposition. Alternatively, a temporary tool such as a funnel shaped guideon a handle may be provided, to facilitate introduction of the tensionband into the bore.

As shown in FIG. 5, a first tension band 120 can be installed in thevertebrae 170, 172, and 174 by passing a first end 121 of the tensionband 120 through the hole 113 from left to right, through the hole 111from right to left and then inferiorly in the direction of thecorresponding connector. A second end 123 of the tension band 120 may bepassed through the hole 115 from left to right and then through hole 111from right to left and then inferiorly in the direction of the connectoras shown in FIGS. 6A and 6B. That way, both ends 121, 123 of the tensionband 120 extend out of the hole 111. Both ends of the tension band 120may be pulled downward as shown by arrows 150 and 152 and secured undertension. FIGS. 6A and 6B illustrate posterior and sagittal views,respectively, of the tension band 120 installed in the vertebrae 170,172, and 174 after steps described above.

In some embodiments, the tension band may thread past the UIV+1/−1.Thus, the tension bands may extend to UIV+2/−2, UIV+3/−3, etc. In someembodiments, the tension bands may equally extend from UIV (e.g., extendbetween +2/−2). In alternate embodiments, the tension bands may extendunequally from UIV (e.g., extend between +2/−3).

In some embodiments, vertebrae may be skipped. For example, vertebraemay be skipped if anatomy does not allow band passage. Thus, the tensionbands may extend through UIV+1/−1 and move directly to UIV+3/−3. In someembodiments, if a vertebrae is skipped on the + side of UIV, theequivalent UIV − may be skipped as well. In some embodiments, thetension bands may equally extend from UIV. In alternate embodiments, thetension bands may extend unequally from UIV. In some embodiments, thetension bands may extend through the same vertebrae on the positive sideof UIV and the negative side of UIV. In some embodiments, the tensionbands may extend through different vertebrae on the positive side of UIVas compared to the negative side of UIV.

Referring to FIGS. 7 and 8, a second tension band 122 is installed inthe vertebrae 170, 172, and 174 in a mirror image configuration. A firstend 125 of the tension band 122 is passed through the hole 115 anddirected towards the connector. A second end 127 of the second tensionband 122 may be passed through the hole 113 from right to left, and thenthrough the hole 111 and from left to right. That way, both ends 125,127 of the tension band 122 exit the same side of hole 111. Both ends125, 127 of the tension band 120 may be pulled downward as shown byarrows 156 and 158 in FIG. 7. FIG. 8 illustrates a posterior view of thetension bands 120 and 122 installed in the vertebrae 170, 172, and 174after steps described above. It will be appreciated that steps describedin FIGS. 5-6B may occur before, after, or simultaneous with thosedescribed in FIGS. 7-8. FIGS. 19A-19E illustrate additional views of thetwo tension band methodology. As shown, one of the tension bands can beattached to a left rod and the other can be attached to the right rod.In some embodiments, the tension band can be attached to rods directly,or to existing portions of the instrumentation or the patient'svertebrae.

While the above discloses one method for installing tension bands, itwill be understood that other methods could be used as well. Forexample, ends of the tension band could be adhered within the holes inthe vertebrae, and thus the tension band may only have one free end forapplying tension. In some embodiments, the tension band could bechemically (e.g., glued, cemented, epoxied) or mechanically adheredwithin the holes in the vertebrae. In some embodiments, the tension bandcould be attached directly to the vertebrae. In some embodiments, thetension band could be connected with an intermediate component that canfit within the holes in the vertebrae, and the intermediate componentcan be attached to the vertebrae.

FIGS. 20A-B illustrate example methods for a single tension band 120which can be used as an alternative to the dual tension bands discussedabove. FIG. 20A illustrates a dual passage approach, where the tensionband 120 may be looped through each of the holes 111/113/115 twice. Asshown, moving from the right connector to the left connector, the band120 may pass through hole 111 from right to left, through hole 113 fromleft to right, back through hole 111 from right to left, back throughhole 113 from left to right, through hole 115 from right to left, backthrough hole 113 from left to right, through hole 115 from right toleft, back through hole 113 from left to right, and back through hole111 from right to left before attaching to a left connector.

Alternatively, a single passage approach can be used as shown in FIG.20B. As shown, starting from the right connector, the band 120 can passthrough hole 111 from right to left, through hole 113 from left toright, through hole 115 from right to left, back through hole 113 fromleft to right, and back through hole 111 from right to left beforeconnecting to the left connector.

Different loop configurations can be used as well, and the describedmethodology is not so limiting. In some embodiments, the holes111/113/115 can include separate lumens for each time the band 120passes through the lumens. In some embodiments, the band may enter thesame lumen multiple times.

In some embodiments, one end of the tension band 120 may connected to aleft rod and the other to a right rod, for example through theconnectors discussed herein.

In some embodiments, one or more of the tension bands can bere-tensioned after a period of time. For example, re-tensioning canoccur every month, six months, one year, or two years. This can be doneautomatically, such as having the connector be configured to be rotated,such as through the use of an electrical connection, or manually throughsurgery. In some embodiments, the tension bands can be replaced after aperiod of time. In some embodiments, the tension bands will never haveto be re-tensioned or replaced.

Alternate connectors 140 are illustrated in FIGS. 15-18. Referring toFIG. 15, connector 140 includes a first locking interface such asconduit 211, for receiving a rod there through. A locking screw 216 isaligned to lock the rod into a longitudinal recess 217 as has beendiscussed.

At least one tension band conduit 213, and preferably a first tensionband conduit 213A and a second tension band conduit 213B are providedfor receiving the two inferiorly extending free ends of the tensionband. At least one and preferably both openings of each tension bandconduit 213A and 213B are provided with a tapered opening 230 tofacilitate threading a free end of the tension band there through.

In the illustrated embodiment, a single locking screw 220 is configuredto compress both tension band ends, extending through respectiveconduits 213A and 213B. Alternatively, a separate locking screw 220A and220B (not illustrated) may be provided for each of the tension bandconduits 213A and 213B respectively.

Each of the tension band conduits 213A and 213B, and the rod conduit 211has a central longitudinal axis. All three of the central longitudinalaxes extend approximately in parallel to each other, and preferablydeviate from parallel by no more than about 15°, no more than about 10°,and in many embodiments no more than about 5° or 2° so that when mountedon a rod, the longitudinal axis of the tension band conduits extend in agenerally inferior-superior direction in alignment with the inferiorlyextending ends of the tension bands following exit from the spinousprocess aperture. The connector may be attached to the rod such that thetension band conduits are on the medial side of the rod, to allow thetension bands to provide a downward and medial bias on the connectedspinous processes. In an embodiment (not illustrated) configured to lockto a cross bar, the longitudinal axes of the conduit 211 may be modifiedaccordingly, but the longitudinal axes of the tension band conduits willpreferably maintain the inferior-superior orientation to avoid bendingthe tension band.

FIGS. 17 and 18 illustrate alternate connectors 240. Connector 240 caninclude any of the features discussed above with respect to theconnectors 140 FIGS. 3A-3C and FIGS. 15-16. Connector 240 can alsoinclude additional unique features.

For example, the direction of the tension band conduits 213A/213B can becranio caudal. Additionally, the connector 240 can have a dualindependent locking mechanism for the rods and the bands.

Further, in the side mounting embodiment, a lateral opening 232 isprovided in the sidewall 230, to allow the connector 240 to be advancedlaterally onto the rod. This allows the surgeon to position the deviceon the rod once the construct is in place.

A circumferentially extending projection from the body such as anaxially extending lip 234 is located adjacent longitudinal recess 217,to enable the rod to be entrapped within longitudinal recess 217 bydistal advance of the locking screw 216. This construct enablesattachment of the connector 240 after the rod has been fully secured toone or more bones screws to complete the posterior instrumentation.

Punching

FIGS. 9-13 illustrate embodiments of distal ends of a pliers typeinstrument (e.g., punch, punch instrument, pin, pin instrument) 300configured for providing “punches” to create holes in the vertebrae asdiscussed above. Accordingly, the instruments 300 can allow a surgeon topunch a hole through the spinous process. The functional part (e.g.,distal end) shown in the figures can include two components, male 302and female 304, working together to punch through the bone. The punchcan form different shaped holes (e.g., round, oval, square, triangular),and the particular shape is not limiting. Generally, the punchinstrument may include two pivotably connected arms 306 which areconnected proximal to functional distal ends. For example, the arms canbe pivotably connected similarly to scissors or forceps.

As shown in FIG. 9, in some embodiments the punch instrument 300 wherethe male component 302 can be solid. The male component 302 can abut thefemale component 304 in the closed position to provide the punch. Asshown, the male component 302 can be tapered/pointed or have a sharppoint/edge for cutting through bone. In some embodiments, the male andfemale components 302/304 may be hollow, such as shown in FIG. 10. Thefemale component 304 may have a greater diameter than the male component302, and thus the male component 302 can fit within the female component304 in the closed position.

FIG. 11 illustrates an embodiment of a punch instrument 300 positionedat a spinous process. The male component 302 can be solid and the femalecomponent 304 can be, for example, hollow, in order to receive the malecomponent 302 in the closed position. Both components 302/304 penetratethe bone 310 to create the punch hole. In this implementation, a tubularfemale component 304 could be detachable to remain in the bone and serveas a liner or grommet to isolate the bone structures when the tensionband in introduced. In some embodiments, the female component 304 is notdetachable.

FIG. 12 illustrates an embodiment of a punch instrument 300 where againthe male component 302 is a solid component and the female component 304is hollow. As compared to FIG. 11, this embodiment shows a shorterfemale component 304. Thus, in this embodiment, only the male component302 penetrates the bone 310 to create the punch hole. The femalecomponent 304 is intended to penetrate the bone 310 only superficiallyin order to stabilize the instrument and avoid the instrument 300 fromslipping.

FIG. 13 illustrates an embodiment of a punch instrument 300 in which themale component 302 is hollow and long enough to extend at least about80% or 90% or entirely the width of the spinous process 310, and thefemale component 304 is hollow and short. Only the male component 302penetrates the bone 310 to create the punch hole. The female component304 is intended to penetrate the bone 310 superficially in order toavoid the instrument from slipping. The band can be introduced throughthe hollow male component 302 which may be detachable to form a tubularbore liner.

FIG. 14 illustrates an embodiment of a grommet 312 in position in bone310, which may have been deployed from a conventional pliers typegrommet tool, or by the hole punch described herein. As shown, thegrommet 312 can remain within the vertebrae after forming the punch. Thegrommet 312 can be useful for creating a smoother or rougher surface forextending the tension band through. Further, as shown, the grommet 312can extend over edges of the hole, reducing any sharp surface there.Thus, it may prevent the band from catching or breaking duringapplication/tension.

Accordingly, there are a number of options to introduce the tension bandthrough the spinous process. For example, the tension band can extenddirectly through the bone, or through a grommet 312 such as discussedabove. The grommet can be incorporated into the punching instrument sothat the grommet 312 remains after punching, or can be introduced afterthe punch hole is formed.

System Kit

The above-described equipment/components can be included in a kit. Theequipment may be contained within a container, such as a bag, box, etc.,or may be separate and loose. The kit can include, for example, one ormore tension bands (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) and one ormore of any of the connectors discussed above (e.g., 1, 2, 3, 4, 5, 6,7, 8, 9, or 10). The connectors can all be the same, or there can be avariety of connectors. The kit can further include liners, bone punches,or grommets as discussed above. No particular equipment is required, andsome kits may include more or less equipment. In some embodiments,alcohol swabs, betadine, cloth, or other equipment can further beincluded, and the discussion herein should not be so limited.

Implementing Systems and Terminology

Implementations disclosed herein provide systems, methods and apparatusfor limiting flexion of vertebrae and/or inhibiting adjacent levelkyphosis or adjacent level failure by way of a vertebral osteosynthesisequipment comprising a tension band.

As used herein, “distal” refers to the end of a tool positioned closestto the patient during use, and “proximal” refers to the end of a toolpositioned closest to the operator (e.g., a physician). Stateddifferently, the relative positions of components of a tool aredescribed herein from the vantage point of the operator.

It should be noted that the terms “couple,” “coupling,” “coupled” orother variations of the word couple as used herein may indicate eitheran indirect connection or a direct connection. For example, if a firstcomponent is “coupled” to a second component, the first component may beeither indirectly connected to the second component via anothercomponent or directly connected to the second component.

From the foregoing description, it will be appreciated that inventivetensioning systems, kits, and methods of use are disclosed. Whileseveral components, techniques and aspects have been described with acertain degree of particularity, it is manifest that many changes can bemade in the specific designs, constructions and methodology herein abovedescribed without departing from the spirit and scope of thisdisclosure.

Certain features that are described in this disclosure in the context ofseparate implementations can also be implemented in combination in asingle implementation. Conversely, various features that are describedin the context of a single implementation can also be implemented inmultiple implementations separately or in any suitable subcombination.Moreover, although features may be described above as acting in certaincombinations, one or more features from a claimed combination can, insome cases, be excised from the combination, and the combination may beclaimed as any subcombination or variation of any subcombination.

Moreover, while methods may be depicted in the drawings or described inthe specification in a particular order, such methods need not beperformed in the particular order shown or in sequential order, and thatall methods need not be performed, to achieve desirable results. Othermethods that are not depicted or described can be incorporated in theexample methods and processes. For example, one or more additionalmethods can be performed before, after, simultaneously, or between anyof the described methods. Further, the methods may be rearranged orreordered in other implementations. Also, the separation of varioussystem components in the implementations described above should not beunderstood as requiring such separation in all implementations, and itshould be understood that the described components and systems cangenerally be integrated together in a single product or packaged intomultiple products. Additionally, other implementations are within thescope of this disclosure.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include or do not include, certain features, elements,and/or steps. Thus, such conditional language is not generally intendedto imply that features, elements, and/or steps are in any way requiredfor one or more embodiments.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than or equal to 10% of, within less than or equal to 5% of, withinless than or equal to 1% of, within less than or equal to 0.1% of, andwithin less than or equal to 0.01% of the stated amount. If the statedamount is 0 (e.g., none, having no), the above recited ranges can bespecific ranges, and not within a particular % of the value. Forexample, within less than or equal to 10 wt./vol. % of, within less thanor equal to 5 wt./vol. % of, within less than or equal to 1 wt./vol. %of, within less than or equal to 0.1 wt./vol. % of, and within less thanor equal to 0.01 wt./vol. % of the stated amount.

The disclosure herein of any particular feature, aspect, method,property, characteristic, quality, attribute, element, or the like inconnection with various embodiments can be used in all other embodimentsset forth herein. Additionally, it will be recognized that any methodsdescribed herein may be practiced using any device suitable forperforming the recited steps.

While a number of embodiments and variations thereof have been describedin detail, other modifications and methods of using the same will beapparent to those of skill in the art. Accordingly, it should beunderstood that various applications, modifications, materials, andsubstitutions can be made of equivalents without departing from theunique and inventive disclosure herein or the scope of the claims.

1.-13. (canceled)
 14. A system of inhibiting proximal junctional failurein a patient having posterior spinal instrumentation, the systemcomprising: at least one tension band having a first end and a secondend; at least one connector configured to be attached to the patient'sspine or the posterior spinal instrumentation; and wherein the at leastone tension band is configured to pass through a plurality of transversebores in at least two vertebrae of the patient's spine; wherein thefirst end of the at least one tension band and the second end of the atleast one tension band are locked under tension in the at least oneconnector.
 15. The system of claim 14, wherein the system furthercomprises a bone punch configured to create the plurality of transversebores.
 16. The system of claim 14, wherein the system comprises aplurality of connectors and wherein the first end of the at least onetension band is locked under tension in a first of the plurality ofconnectors and the second end of the at least one tension band is lockedunder tension in a second of the plurality of connectors.
 17. The systemof claim 16, wherein the first of the plurality of connectors and thesecond of the plurality of connectors are configured to be located onopposite transverse sides of the patient's spine.
 18. The system ofclaim 14, wherein the at least one tension band comprises a firsttension band and a second tension band each having a first end and asecond end, and wherein the at least one connector comprises a firstconnector and a second connector, wherein the first end and the secondend of the first tension band are locked under tension in the firstconnector, and wherein the first end and the second end of the secondtension band are locked under tension in the second connector.
 19. Thesystem of claim 18, wherein the first connector and the second connectorare configured to be located on opposite transverse sides of thepatient's spine.
 20. A kit containing the system of claim 15.